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CStone Pharmaceuticals announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending approval of sugemalimab in combination with chemotherapy as a first-line treatment for metastatic non-small cell lung cancer, which is one of the largest cancer indications and a leading cause of cancer death in the world.

Unnamed sources “familiar with the matter” informed Bloomberg that CStone’s leadership team is working with Goldman Sachs to determine if there are interested buyers.

CStone Pharmaceuticals, announced the presentation of the final progression-free survival analysis results from the registrational GEMSTONE-301 study of sugemalimab as a consolidation therapy in patients with unresectable stage III non-small cell lung cancer whose disease had not progressed after concurrent or sequential chemoradiotherapy at the IASLC 2022 World Conference on Lung Cancer.

CStone Pharmaceuticals and Pfizer Inc. announced that the National Medical Products Administration of China has approved sugemalimab for the treatment of patients with unresectable stage III non-small cell lung cancer whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy.

CStone Pharmaceuticals (“CStone”, HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, today announced that the first patient has been enrolled in the U.S. in the Phase 1 clinical trial for CS5001.

Today, the FDA approved two new drug applications. One is for Spero’s tebipenem HBr oral tablets and the second is CStone’s IND application for CS5001.

The November layoffs are the second known workforce reduction this year for Marinus Pharmaceuticals, which previously announced disappointing Phase III results for ganaxolone in two clinical trials.

CStone Pharmaceuticals, a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, and Jiangsu Hengrui Pharmaceuticals announced a strategic partnership and exclusive licensing agreement on anti-CTLA-4 mAb CS1002 in the Greater China region.